Program Manager Product Development

Nova Biomedical • Waltham, MA

13h • Onsite

About The Position

The Program Manager owns end-to-end execution of assigned new product development and product-sustaining programs, from project proposal through commercial launch and post-launch surveillance. The role is the single point of accountability for program delivery, maintaining an integrated plan, committed dates, and a credible view of program status. Product Management owns Voice of Customer, market requirements definition, and the NPV/business case; the Program Manager ensures functional leaders deliver stage-gate commitments on time, to the required quality, and in the right sequence. Success is measured by milestone achievement and gate readiness across the portfolio.

The Program Manager manages the integrated plan, milestones, operating cadence, program status reporting, budget, and cost-saving opportunities. The role leads Nova’s stage-gate governance, prepares gate reviews, confirms deliverable completeness, and ensures tailoring decisions are documented and approved. It also manages sustaining and lifecycle work, including post-release design changes, reliability and cost-down initiatives, obsolescence, field feedback, and product end-of-life planning.

The role executes programs in accordance with design controls, risk management, software lifecycle and cybersecurity requirements, and applicable regulations. It ensures design history file completeness and audit readiness, partnering with Quality and Regulatory on documentation, classification, submission timing, and evidence. The Program Manager actively manages risks, issues, dependencies, and resource contention, and leads cross-functional teams without direct authority. The position also improves program management practices and provides leadership with visibility into program health, capacity, trade-offs, and prioritization recommendations.

This is an onsite role in Waltham, Massachusetts. The targeted salary range is $190,000–$270,000 per year. Nova Biomedical describes itself as a global organization with nearly 2,000 employees.

Requirements

• Bachelor’s degree in engineering, life sciences, or a related technical discipline.
• At least 7 years of experience in product development, program management, or project management.
• At least 3 years leading cross-functional programs end to end.
• Demonstrated ownership of at least one product program from concept through commercial launch in a regulated medical device, IVD, diagnostics, or life science instrumentation environment.
• Working fluency in stage-gate medical device and/or diagnostic development, design controls, and risk management within an ISO 13485 / FDA QMSR quality system.
• Experience managing both new product development and sustaining/lifecycle programs, including design changes and field corrective actions, and managing change implementation across the global regulatory landscape.
• Proven ability to hold senior cross-functional leaders accountable to commitments without direct reporting authority.
• Strong command of program management tools, schedule and critical-path management, and executive-level status reporting.
• Ability to work at a computer for extended periods.
• Ability to lift and carry up to 25–50 pounds as required.
• Ability to communicate effectively by phone, video, and written communication.
• Ability to occasionally move about the office to access meetings or resources.

Nice To Haves

• PMP, PgMP, or equivalent program management certification.
• Experience with instrumentation, consumables, and software combination programs.
• Experience managing a portfolio of concurrent programs with shared resources.
• Exposure to design transfer, process validation, and manufacturing scale-up.

Responsibilities

• Own and maintain an integrated cross-functional program plan covering scope, schedule, resources, deliverables, dependencies, and critical path throughout the product lifecycle.
• Manage assigned programs through stage gates from inception through launch and post-launch surveillance.
• Drive milestone accountability by identifying slippage, facilitating trade-off discussions, and creating recovery plans with owners and dates.
• Lead core team meetings, drive decisions to closure, document commitments, and escalate blockers to functional leadership.
• Maintain program status reporting for core teams, leadership, and portfolio reviews, including schedule health, risks, issues, dependencies, and decisions required.
• Develop and manage program budgets, track actuals, forecast financial performance, and identify cost-saving opportunities.
• Prepare and lead gate reviews, assemble gate packages, verify deliverables, surface risks and exceptions, and secure documented approval to progress.
• Ensure tailoring of deliverables is justified, documented, and approved.
• Manage sustaining programs, including post-release design changes, reliability and cost-down initiatives, component obsolescence, and cross-product changes.
• Translate complaints, CAPA, service data, and post-market surveillance findings into prioritized, scheduled, and resourced sustaining work.
• Coordinate product discontinuation and end-of-life transition planning across regulatory, service, spare parts, labeling, and customer communications.
• Execute programs in accordance with design and development procedures, design controls, risk management, software lifecycle and cybersecurity requirements, and applicable regulations.
• Maintain design history file index completeness and audit readiness throughout each program and confirm records are current at each gate.
• Partner with Quality and Regulatory to align documentation, classification, submission timing, and evidence requirements with program schedules and target markets.
• Maintain program risk registers and mitigation and contingency plans for technical, supply, regulatory, resource, and launch risks.
• Manage intra-program and cross-program dependencies, identify resource and sequencing conflicts, and escalate resource contention with options and impact.
• Escalate issues with a clear problem statement, options, impact, and recommended path.
• Lead peers and senior functional leaders in a matrixed organization, resolving conflict and holding them accountable without direct authority.
• Improve program management practices, templates, metrics, and reporting standards; coach functional leads and project managers on gate expectations.
• Provide leadership with visibility into program health, capacity constraints, trade-offs, and prioritization recommendations.

Benefits

• Flexible medical, dental, and vision coverage.
• Competitive 401(k) company match.
• Bonus program.
• Generous paid time off and paid holidays.
• Tuition reimbursement.
• Hybrid and flexible work arrangements.
• Professional development, engagement, and events.
• Company marketplace for lunch and snacks at the Norwood, Billerica, and Westbrook offices.
• Company-subsidized cafeteria at the Waltham office.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior